Pembrolizumab
- Generic Name
- Pembrolizumab
- Brand Names
- Keytruda
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 1374853-91-4
- Unique Ingredient Identifier
- DPT0O3T46P
- Background
Pembrolizumab is a highly selective IgG4-kappa humanized monoclonal antibody against PD-1 receptors. It was generated by grafting the variable sequences of a very high-affinity mouse antihuman PD-1 antibody onto a human IgG4-kappa isotype containing a stabilizing S228P Fc mutation. It contains 32 cysteine residues and the complete folded molecule includes 4 disulfide linkages as interchain bonds and 23 interchain bonds. It was developed by Merck & Co and first approved for the treatment of metastatic malignant melanoma by the FDA on September 4, 2014, becoming the first approved therapy against PD-1. In the time since its initial approval, pembrolizumab has been granted approval in the treatment of a wide variety of cancers.
- Indication
Pembrolizumab is indicated for the following conditions:
For all approved adult indications, pembrolizumab may be used for an additional 6 weeks at 400mg weekly.
- Associated Conditions
- Advanced Endometrial Cancer, Advanced Renal Cell Carcinoma, Hepatocellular Carcinoma, Locally Advanced Cutaneous Squamous Cell Carcinoma, Locally Advanced or Metastatic Urothelial Carcinoma (UC), Metastatic Adenocarcinoma of the Gastroesophageal Junction, Metastatic Cervical Cancer, Metastatic Esophageal Carcinoma, Metastatic Melanoma, Metastatic Non-Small Cell Lung Cancer, Metastatic Renal Cell Carcinoma ( mRCC), Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC), Metastatic Triple Negative Breast Cancers, Metastatic Urothelial Carcinoma (UC), Metastatic cutaneous squamous cell carcinoma, Metastic Renal Cell Carcinoma, Non-Small Cell Lung Cancer (NSCLC), Nonsmall Cell Lung Cancer, Stage II, Persistent Cervical Cancer, Recurrent Cervical Cancer, Refractory Primary Mediastinal Large B-Cell Cell Lymphoma, Renal Cell Carcinoma (RCC), Resectable Non-small Cell Lung Cancer, Stage IB Non-small Cell Lung Cancer, Stage IIB Melanoma, Stage IIC Melanoma, Stage III Melanoma, Stage IIIA Non Small Cell Lung Cancer, Unresectable Melanoma, Advanced Microsatellite Instability High Endometrial Carcinoma, Advanced Mismatch Repair-deficient (dMMR) Endometrial Carcinoma, High risk, early Triple Negative Breast Cancer, High risk, in situ Non-Muscle Invasive Bladder Cancer (NMIBC) Refractory to BCG, Locally advanced Adenocarcinomas of the Gastroesophageal Junction, Locally advanced Esophageal Carcinoma, Locally advanced Urothelial Carcinoma, Metastatic HER2-positive Adenocarcinoma of the Stomach, Metastatic HER2-positive Adenocarcinomas of the Gastroesophageal Junction, Metastatic High Tumor Mutation Burden Solid Tumors, Metastatic Merkel Cell Carcinoma (MCC), Metastatic Microsatellite Instability High Colorectal Cancer, Metastatic Microsatellite Instability-High (MSI-H) Solid Tumors, Metastatic Mismatch Repair Deficient Colorectal Cancer, Metastatic Mismatch repair deficient (dMMR) solid tumors, Recurrent Cutaneous Squamous Cell Carcinoma, Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN), Recurrent, locally advanced Adenocarcinomas of the Gastroesophageal Junction, Recurrent, locally advanced Merkel Cell Carcinoma, Refractory Classical Hodgkin's Lymphoma, Relapsed Classical Hodgkin's Lymphoma, Stage 3 Non-Small Cell Lung Carcinoma (NSCLC), Unresectable High Tumor Mutation Burden Solid Tumors, Unresectable Microsatellite Instability High Colorectal Cancer, Unresectable Microsatellite Instability-High (MSI-H) Solid Tumors, Unresectable Mismatch Repair Deficient Colorectal Cancer, Unresectable Mismatch repair deficient (dMMR) solid tumors, Unresectable, locally advanced HER2-positive Adenocarcinoma of the Stomach, Unresectable, locally advanced HER2-positive Adenocarcinomas of the Gastroesophageal Junction, Unresectable, locally recurrent Triple Negative Breast Cancer, Unresectable, recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- Associated Therapies
- -
A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer
- Conditions
- Interventions
- First Posted Date
- 2023-11-07
- Last Posted Date
- 2024-11-13
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 1016
- Registration Number
- NCT06119581
- Locations
- 🇺🇸
Cedars-Sinai Medical Center, Los Angeles, California, United States
🇺🇸Highlands Oncology Group, Springdale, Arkansas, United States
🇦🇹Ordensklinikum Linz GmbH Elisabethinen, Linz, Oberösterreich, Austria
Study Evaluating Pembrolizumab +/- Olaparib in TLS Positive Selected Resectable STS Followed by Adjuvant Pembrolizumab
- Conditions
- Interventions
- First Posted Date
- 2023-11-03
- Last Posted Date
- 2024-04-17
- Lead Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Target Recruit Count
- 36
- Registration Number
- NCT06116578
- Locations
- 🇫🇷
Gustave Roussy, Villejuif, Val De Marne, France
Palbociclib and Pembrolizumab in Undifferentiated Pleomorphic Sarcoma (UPS)
- Conditions
- Interventions
- First Posted Date
- 2023-11-02
- Last Posted Date
- 2024-07-26
- Lead Sponsor
- John Rieth
- Target Recruit Count
- 8
- Registration Number
- NCT06113809
- Locations
- 🇺🇸
University of Iowa Hospitals & Clinics, Iowa City, Iowa, United States
A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer
- First Posted Date
- 2023-11-01
- Last Posted Date
- 2024-12-19
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 1728
- Registration Number
- NCT06112379
- Locations
- 🇻🇳
Research Site, Vinh, Vietnam
Neratinib In Combination With Chemotherapy/Trastuzumab/Pembrolizumab In HER2 Gastroesophageal Cancer
- Conditions
- Interventions
- First Posted Date
- 2023-10-31
- Last Posted Date
- 2024-05-03
- Target Recruit Count
- 36
- Registration Number
- NCT06109467
- Locations
- 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors
- Conditions
- Interventions
- First Posted Date
- 2023-10-30
- Last Posted Date
- 2024-12-06
- Lead Sponsor
- Jazz Pharmaceuticals
- Target Recruit Count
- 177
- Registration Number
- NCT06108050
- Locations
- 🇺🇸
California Cancer Associates for Research and Excellence, Fresno, California, United States
🇺🇸Duke University Medical Center - Duke Cancer Institute, Durham, North Carolina, United States
🇺🇸Sidney Kimmel Cancer Center at Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer
- Conditions
- Interventions
- First Posted Date
- 2023-10-27
- Last Posted Date
- 2024-11-25
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 625
- Registration Number
- NCT06103864
- Locations
- 🇻🇳
Research Site, Vinh, Vietnam
Evaluating the Efficacy and Safety of Pembrolizumab Plus Standard Chemotherapy in the Neoadjuvant Treatment of Local Advanced (LA) HNSCC
- First Posted Date
- 2023-10-26
- Last Posted Date
- 2023-10-30
- Lead Sponsor
- Beijing Tongren Hospital
- Target Recruit Count
- 272
- Registration Number
- NCT06102395
- Locations
- 🇨🇳
Beijing Tongren Hospital, Beijing, Beijing, China
A Study of Participant Reported Preference for Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Over Intravenous Pembrolizumab (MK-3475) Formulation in Multiple Tumor Types (MK-3475A-F11)
- Conditions
- Interventions
- First Posted Date
- 2023-10-25
- Last Posted Date
- 2024-11-29
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 144
- Registration Number
- NCT06099782
- Locations
- 🇺🇸
Russell Medical ( Site 0160), Alexander City, Alabama, United States
🇺🇸Alaska Oncology and Hematology ( Site 0121), Anchorage, Alaska, United States
🇺🇸Highlands Oncology Group-Research Department ( Site 0133), Springdale, Arkansas, United States
Efficacy and Safety of PD-1 Plus Chemotherapy in Poorly Differentiated Locally Advanced (LA) HNSCC
- Conditions
- Interventions
- First Posted Date
- 2023-10-25
- Last Posted Date
- 2024-08-09
- Lead Sponsor
- Beijing Tongren Hospital
- Target Recruit Count
- 100
- Registration Number
- NCT06100497
- Locations
- 🇨🇳
Beijing Tongren Hospital Affiliated to Capital Medical University, Beijing, Beijing, China
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.